← Product Code [JDI](/productcode/JDI) · K253434 # OSSTM Orthopedic Salvage System (K253434) _Biomet, Inc. · JDI · Jul 1, 2026 · Orthopedic · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K253434 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JDI](/productcode/JDI.md) - **Decision Date:** Jul 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3350 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use OSS System Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Ligament deficiencies. • Tumor resections. • Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * • Revision of previously failed total joint arthroplasty. • Trauma. These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Tumor resections. • Revision of previously failed total joint arthroplasty. • Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information. ## Device Story Modular orthopedic salvage system; provides proximal femoral, distal femoral, total femur, or proximal tibial replacements; includes resurfacing components. Used for bone loss/deformity from tumor resection, trauma, or revision arthroplasty. Components typically cemented; OsseoTi titanium alloy components uncemented. Compress Segmental Femoral Replacement System used for uncemented fixation. Operated by surgeons in clinical/surgical settings. System restores joint function and skeletal stability following significant bone loss or failure of previous implants. ## Clinical Evidence No clinical data. Bench testing only. Process validations performed to confirm manufacturing changes meet existing specifications. Fatigue strength, biological safety, and cleaning evaluations conducted. ## Technological Characteristics Modular orthopedic prosthesis; materials include OsseoTi titanium alloy and other unspecified metals/polymers. Designed for cemented or uncemented (Compress system) fixation. Components include proximal/distal femoral, total femur, and proximal tibial replacements. Manufacturing process modified; device performance validated via fatigue testing and biological safety assessments. ## Regulatory Identification A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027). ## Predicate Devices - Orthopedic Salvage System (OSS) ([K123501](/device/K123501.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION July 1, 2026 Biomet, Inc. Yoriko Kobayashi Regulatory Affairs Principal 56 E Bell Dr. Warsaw, Indiana 46581 Re: K253434 Trade/Device Name: OSS™ Orthopedic Salvage System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, KRO Dated: June 2, 2026 Received: June 3, 2026 Dear Yoriko Kobayashi: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K253434 - Yoriko Kobayashi Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K253434 - Yoriko Kobayashi Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LIMIN SUN -S Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253434 | | --- | --- | | Please provide the device trade name(s). | | | OSS™ Orthopedic Salvage System | | | Please provide your Indications for Use below. | | | OSS System Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Ligament deficiencies. • Tumor resections. • Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * • Revision of previously failed total joint arthroplasty. • Trauma. These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Tumor resections. • Revision of previously failed total joint arthroplasty. • Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information. | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | {4} 510(k) #: K253434 # 510(k) Summary Prepared on: 2026-06-02 Contact Details 21 CFR 807.92(a)(1) | Applicant Name | BIOMET, INC. | | --- | --- | | Applicant Address | 56 E Bell Dr Warsaw IN 46581 United States | | Applicant Contact Telephone | 1-800-613-6131 | | Applicant Contact | Yoriko Kobayashi | | Applicant Contact Email | yoriko.kobayashi@zimmerbiomet.com | Device Name 21 CFR 807.92(a)(2) | Device Trade Name | OSS™ Orthopedic Salvage System | | --- | --- | | Common Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | | Classification Name | Hip joint metal/polymer semi-constrained cemented prosthesis | | Regulation Number | 888.3350 | | Product Code(s) | JDI, KRO | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | --- | --- | --- | | K123501 | Orthopedic Salvage System (OSS) | JDI | Device Description Summary 21 CFR 807.92(a)(4) The OSS™ Orthopedic Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. The OSS System offers the surgeon treatments for patients presenting bone loss and deformity associated with bone tumors resection, trauma, and difficult revision arthroplasty. Zimmer Biomet OSS Modular Arthrodesis System and specialty components hip soft tissue claws are also used with the Zimmer Biomet OSS Orthopedic Salvage System. Intended Use/Indications for Use 21 CFR 807.92(a)(5) OSS System Indications: - Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. - Correction of varus, valgus, or posttraumatic deformity. - Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. - Ligament deficiencies. - Tumor resections. - Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.* - Revision of previously failed total joint arthroplasty. - Trauma. These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents {5} (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: - Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. - Tumor resections. - Revision of previously failed total joint arthroplasty. - Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The indications for Use are same between the predicate and the subject device. ## Technological Comparison 21 CFR 807.92(a)(6) The subject device has the same technical characteristics such as design, material, chemical composition, and principal of operation. The modification proposed in this notification is to the manufacturing process of the devices, and non-clinical tests demonstrates the proposed device is as safe and effective as the predicate devices. ## Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Process validations are completed for the proposed manufacturing process changes to confirm that the proposed processes will produce parts meeting the existing product specifications. Device performance (fatigue strength), biological safety and cleaning of the devices have been evaluated and reviewed for potential impact due to the proposed changes. It concluded that there is no significant impact to safety and effectiveness of devices due to the changes. Clinical testing not applicable. The proposed device has the same intended use as the predicate(s). The proposed device has the same technological characteristics to the predicate(s), and the information provided herein demonstrates that: - any differences do not raise different questions of safety and effectiveness; and - the proposed device is at least as safe and effective as the legally marketed predicate device(s). --- **Source:** [https://fda-staging.innolitics.com/device/K253434](https://fda-staging.innolitics.com/device/K253434) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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